Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial

Rickard, Claire M., Marsh, Nicole M., Webster, Joan, Gavin, Nicole C., Chan, Raymond J., McCarthy, Alexandra L., Mollee, Peter, Ullman, Amanda J., Kleidon, Tricia, Chopra, Vineet, Zhang, Li, McGrail, Matthew R., Larsen, Emily, Abu Choudhury, Md, Keogh, Samantha, Alexandrou, Evan, McMillan, David J., Mervin, Merehau Cindy, Paterson, David L., Cooke, Marie, Ray-Barruel, Gillian, Castillo, Maria Isabel, Hallahan, Andrew, Corley, Amanda and Playford, E. Geoffrey (2017) Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial. BMJ Open, 7 6: e015291. doi:10.1136/bmjopen-2016-015291


Author Rickard, Claire M.
Marsh, Nicole M.
Webster, Joan
Gavin, Nicole C.
Chan, Raymond J.
McCarthy, Alexandra L.
Mollee, Peter
Ullman, Amanda J.
Kleidon, Tricia
Chopra, Vineet
Zhang, Li
McGrail, Matthew R.
Larsen, Emily
Abu Choudhury, Md
Keogh, Samantha
Alexandrou, Evan
McMillan, David J.
Mervin, Merehau Cindy
Paterson, David L.
Cooke, Marie
Ray-Barruel, Gillian
Castillo, Maria Isabel
Hallahan, Andrew
Corley, Amanda
Playford, E. Geoffrey
Title Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2017-06-01
Sub-type Article (original research)
DOI 10.1136/bmjopen-2016-015291
Open Access Status DOI
Volume 7
Issue 6
Start page e015291
Total pages 9
Place of publication London, United Kingdom
Publisher BMJ Group
Language eng
Subject 2700 Medicine
Abstract Introduction Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. Methods and analysis Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. Secondary outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. Ethics and dissemination Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. Trial registration Trial registration number is: ACTRN12616000315415.
Keyword Catheter obstruction
Catheter-related infections
Catheterization, Central Venous
Occlusive dressings.
Upper extremity deep vein thrombosis
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID K08 HS022835
Institutional Status UQ

 
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